Clinical trials: Implant Therapy
Symptomatic Cartilage Defects of the Femoral Condyle
Comparison of BioCart™II With Microfracture for Treatment of Cartilage Defects of the Femoral Condyle
BioCart™II is a novel scaffold seeded with autologous chondrocytes to be used to repair cartilage lesions of the knee. This study is designed to compare the efficacy and safety of BioCart™II treatment compared to microfracture…
- Trial name
- NCT00729716
- Testing
- BioCart™II, Microfracture
- Where
- 8 sites in United States, Israel
- Volunteers
- 40 people
- Sponsor
- ProChon Biotech Ltd
Coronary Restenosis
Clinical Evaluation of Patients With Everolimus-eluting Stent Xience V® Implanted in the Treatment of Restenosis in Non-coated Metallic Stent (BMS In-stent Restenosis) During a 2 Year Clinical Follow-up Period
Interventional, prospective, non-randomized, non-comparative, open and multicentric study of patients with everolimus-eluting stent " Xience V® " implanted in the treatment of restenosis in non-coated metallic stent (BMS in-stent…
- Trial name
- XERES (NCT00882219)
- Testing
- Xience V®
- Where
- France
- Volunteers
- 102 people
- Sponsor
- Abbott Medical Devices
Chronic Pain
Clinical Outcomes Study Using a New Implantable Neurostimulation System for Chronic Intractable Pain
The primary objective of this study is to investigate patient satisfaction with treatment using a new implantable neurostimulation system for chronic pain of the trunk and/or limbs.
- Trial name
- NCT01665040
- Testing
- Neurostimulation device implantation
- Where
- 7 sites in Australia, Belgium and 1 more
- Volunteers
- 40 people
- Sponsor
- Boston Scientific Corporation
MPS I
Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-318 in Subjects With MPS I
The purpose of the study is to evaluate the safety, tolerability of ascending doses of SB-318. SB-318 is an intravenously delivered Zinc Finger Nuclease (ZFN) Therapeutic for genome editing.
- Trial name
- NCT02702115
- Testing
- SB-318
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Sangamo Therapeutics
Chronic Pain, Back Pain
Value of Multiple Modalities Using the Spectra WaveWriter Spinal Cord Stimulator System
To demonstrate the value of multiple modalities and sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Spectra WaveWriter Spinal Cord Stimulator (SCS) System.
- Trial name
- VERITAS (NCT03251937)
- Testing
- Spectra WaveWriter SCS System
- Where
- 15 sites in United States
- Volunteers
- 97 people
- Sponsor
- Boston Scientific Corporation
Chronic Total Occlusion of Coronary Artery
To Evaluate Whether IVUS-guided Drug-eluting Stent (DES) Implantation Leads to Better Clinical Outcomes Compared to Conventional Angiography in the Treatment of Chronic Complete Occlusion (CTO) Disease.
This study aims to evaluate the treatment of Chronic total occlusion (CTO) disease. Whether Intravascular Ultrasonography (IVUS) guiding the implantation of drug-eluting stents (DES) will provide better long-term clinical…
- Trial name
- CRUISE-CTO (NCT04944615)
- Testing
- The guidewire successfully passed the CTO lesion
- Where
- China
- Volunteers
- 1,448 people
- Sponsor
- CCRF Inc., Beijing, China
Breast Cancer
SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy
This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy.
- Trial name
- NCT01959867
- Testing
- SurgiMend® PRS, No Intervention
- Sponsor
- Integra LifeSciences Corporation
Articular Cartilage Defect
NOVOCART 3D Treatment Following Microfracture Failure
This study is prospective single arm extension study of protocol AAG-G-H-1220. It is open only to participants of AAG-G-H-1220 randomized to the Microfracture treatment group.
- Trial name
- NCT03219307
- Testing
- NOVOCART 3D
- Where
- 5 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Aesculap Biologics, LLC
Open-Angle Glaucoma
Study to Assess Change in Disease Activity and Adverse Events of Ab Externo Approach for Glaucoma Gel Stent (XEN45) Implantation In Participants Aged 45 Years or Older With Open-Angle Glaucoma
Glaucoma is the second most common cause of blindness in the world, second only to cataracts. This study will assess how safe and effective a glaucoma gel stent is when implanted using the ab externo approach.
- Trial name
- NCT05411198
- Testing
- XEN45 (Glaucoma Gel Stent)
- Where
- 25 sites in United States, Australia
- Volunteers
- 74 people
- Sponsor
- AbbVie
Coronary Artery Disease
Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy
Factorial 2x2, all-comer, multicentre, randomized controlled trial (ratio 1:1:1:1). First, the study will compare (first randomization) the non-inferiority in target lesion failure of angiolite stent versus Xience stent family.
- Trial name
- ANGIODAPT (NCT05952206)
- Testing
- Angiolite: Sirolimus-eluting stent, Xience: Everolimus-eluting stent, 1-month DAPT
- Where
- 38 sites in Belgium, France and 1 more
- Volunteers
- 2,312 people
- Sponsor
- iVascular S.L.U.
Severe Native Calcific Aortic Stenosis, Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis
Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
VOYAGER CE Clinical Study using the Encantor TAVI System.
- Trial name
- VOYAGER CE (NCT07696182)
- Testing
- Prospective, single-arm, multi-center study.
- Volunteers
- 150 people
- Sponsor
- Abbott Medical Devices
Degeneration; Bone
Comparison of a PEG Membrane and a Collagen Membrane for the Treatment of Bone Dehiscence Defects at Bone Level Implants
The aim of the study is to test in a randomized comparative study the performance of Straumann® MembraGel (PEG Membrane) to act as a barrier for guided bone regeneration compared to that of a standard collagen membrane (BioGide®)…
- Trial name
- NCT01012921
- Testing
- barrier membrane, MembraGel, Bio-Gide® membrane
- Where
- 9 sites in Belgium, Germany and 5 more
- Volunteers
- 117 people
- Sponsor
- Institut Straumann AG
Mucopolysaccharidosis II, MPS II
Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-913 in Subjects With MPS II
The purpose of the study is to evaluate the safety, tolerability and effect on leukocyte and plasma Iduronate 2-Sulfatase (IDS) enzyme activity of ascending doses of SB-913.
- Trial name
- NCT03041324
- Testing
- SB-913
- Where
- 5 sites in United States
- Volunteers
- 9 people
- Sponsor
- Sangamo Therapeutics
Ventricular Arrythmias
Efficacy of the ATP Switch Automatic Programming in Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) Implanted Patients
Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple, dual or triple chamber ICD.
- Trial name
- ASAP (NCT01169246)
- Where
- France
- Volunteers
- 1,254 people
- Sponsor
- MicroPort CRM
Vitiligo
Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo
The purpose of this study is to determine whether afamelanotide and narrow band UVB are effective in the treatment of non-segmental vitiligo (NSV).
- Trial name
- NSV (NCT01382589)
- Testing
- Afamelanotide, NB-UVB
- Volunteers
- 15 people
- Sponsor
- Clinuvel Pharmaceuticals Limited
Prosthetic Joint Infection of Knee
Sola2 AMF Knee System Added to Surgery and Antibiotics in Adults With Knee Implant Infection
The goal of this clinical trial is to learn whether the Sola2 AMF Knee System, when added to surgery and antibiotic treatment, can safely improve outcomes, knee function, and quality of life in adults with knee implant infection.
- Trial name
- AMPLIFY (NCT07700927)
- Testing
- Intervention 1: Alternating Magnetic Field Treatment, Debridement, Antibiotics, Implant Retention
- Where
- 2 sites in United States
- Volunteers
- 165 people
- Sponsor
- Solenic Medical, Inc.
Aortic Valve Stenosis
PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery…
- Trial name
- NCT01238835
- Testing
- SAPIEN XT™ Transapical aortic valve replacement
- Where
- 20 sites in Austria, France and 2 more
- Volunteers
- 220 people
- Sponsor
- Edwards Lifesciences
Sleep Apnea Syndromes, Sleep Apnea, Obstructive
Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)
The objective of the study is to determine the safety and preliminary efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).
- Conditions
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiration Disorders, Signs and Symptoms, Respiratory
- Trial name
- NCT01532180
- Testing
- aura6000 System
- Where
- Belgium
- Volunteers
- 14 people
- Sponsor
- ImThera Medical, Inc.
Tachyarrhythmias, Sudden Cardiac Death
SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients
The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.
- Conditions
- Tachyarrhythmias, Sudden Cardiac Death, Heart Failure
- Trial name
- NCT00940888
- Testing
- SJ4 connector and RV high voltage SJ4 lead
- Where
- United States
- Volunteers
- 1,701 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Congestive
Home Monitoring in Cardiac Resynchronisation Therapy
In spite of success in the management of heart failure, repetitive rehospitalisation and high mortality rate remain a serious problem.
- Trial name
- HomeCARE (NCT00376116)
- Testing
- Cardiac resynchronisation therapy, Implantable cardioverter-defibrillator
- Where
- 82 sites in Austria, Czechia and 8 more
- Volunteers
- 513 people
- Sponsor
- Biotronik SE & Co. KG